Effects and Mechanisms of Treatment Intensity of Mirror Therapy in Patients With Subacute Stroke

Completed

Phase N/A Results N/A

Trial Description

The purpose of this study will evaluate the long-term benefits, optimal dose and mechanisms of mirror therapy and its effects on physiological markers.

Detailed Description

This trial is to examine whether (1) the immediate effects of treatment intensity in MT would occur on sensorimotor impairments and functional performance in patients with subacute stroke; (2) the long-term benefits of treatment intensity in MT on functionality can persist for six months after treatment finished; and (3) the MT could result in cortical/movement reorganization as well as the changes in physiological markers.

Conditions

Interventions

  • Control intervention group Behavioral
    Other Names: CI
    Intervention Desc: The CI group will carry out a 30-minute conventional stroke rehabilitation training per session followed by a 30-minute functional training.
    ARM 1: Kind: Experimental
    Label: control intervention group
    Description: The part of this project will involve 1 treatment groups:control intervention group (CI)
  • MT with low-intensity group (MT-LI) Behavioral
    Other Names: MT-LI
    Intervention Desc: The MT-LI group will receive a 30-minute MT per session followed by a 30-minute functional training.
    ARM 1: Kind: Experimental
    Label: mirror therapy treatment
    Description: Three groups will be involved in this part of the whole project:MT with low-intensity group (MT-LI), MT with moderate-intensity group (MT-MI), MT with high-intensity group (MT-HI)
  • MT with moderate-intensity group Behavioral
    Other Names: MT-MI
    Intervention Desc: The MT-MI group will receive a 60-minute MT per session followed by a 30-minute functional training.
    ARM 1: Kind: Experimental
    Label: mirror therapy treatment
    Description: Three groups will be involved in this part of the whole project:MT with low-intensity group (MT-LI), MT with moderate-intensity group (MT-MI), MT with high-intensity group (MT-HI)
  • Mirror therapy with high intensity group Behavioral
    Other Names: MT-HI
    Intervention Desc: The MT-HI group will receive a 90-minute MT per session followed by a 30-minute functional training
    ARM 1: Kind: Experimental
    Label: mirror therapy treatment
    Description: Three groups will be involved in this part of the whole project:MT with low-intensity group (MT-LI), MT with moderate-intensity group (MT-MI), MT with high-intensity group (MT-HI)

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Fugl-Meyer Assessment (FMA) Baseline, change from baseline in FMA at 2 weeks, and change from baseline in FMA at 4 weeks No
Primary Action Research Arm Test (ARAT) Baseline, change of ARAT at 2 weeks, and change of ARAT at 4 weeks No
Primary Motor Activity Log (MAL) Baseline, change of MAL at 2 weeks, and change of MAL at 4 weeks No
Primary ABILHAND Questionnaire Baseline, change of ABILHAND Questionnaire at 2 weeks, and change of ABILHAND Questionnaire at 4 weeks No
Primary Adelaide Activities Profile (AAP) Baseline, change of AAP at 2 weeks, and change of AAP at 4 weeks No
Secondary Functional magnetic resonance imaging (fMRI) Baseline and change of fMRI at 4 weeks No
Secondary Physiological marker measures Baseline and change from baseline in physiological marker measures at 4 weeks No

Sponsors